Access to antiretroviral therapy (ART) is still limited in Africa (11% of patients in immediate need in June 2005). Face to the scope of the need and the constraints (unavailability and cost of viral load and CD4 cell count, lack of physicians…), WHO has developed a follow-up approach based on a simplified monitoring. However, this "simplified" approach which represents a major stake for the expanded access to ART has been little evaluated against the gold standard approach.

some clinical consultations will be performed by nurses under the physicians' responsibility ;

the CD4 cell count and HIV-1 viral load will not be available for the management of patients ;

the biologic assessment for tolerability will be limited

No Intervention: 2

Standard treatment follow-up

Procedure: Standard follow-up approach of ARV treatment

Standard treatment follow-up :

all clinical consultations will be performed by physicians ;

the CD4 cell count and HIV-1 viral load will be available for the patients management routinely ;

the biologic assessment for tolerability will be available as needed

Detailed Description:

Justification

Access to antiretroviral therapy (ART) is still limited in Africa (11% of patients in immediate need in June 2005). Face to the scope of the need and the constraints (unavailability and cost of viral load and CD4 cell count, lack of physicians…), WHO has developed a follow-up approach based on a simplified monitoring. This "simplified" approach restricting the use of complementary exams including biologic criteria of effectiveness and tolerability, some people consider this approach as dangerous for the patient but also for the community (rapid emergence of resistances) and that it would be preferable to treat less patients and only with the gold standard approach. In practice, this "simplified" approach which represents a major stake for the expanded access to ART has been little evaluated against the gold standard approach.

Objectives

Main objective: To compare the increase in the CD4 cell count in patients receiving ART with a "simplified" approach and in those treated with the gold standard approach in district hospitals.

Secondary objectives: To compare between the two approaches the virologic effectiveness, survival, treatment interruptions, number of patients lost to follow-up, clinical progression, clinical and biologic tolerability, adherence, emergence of drug resistances, impact on patients' daily life, acceptability by the patients and health professionals, and cost-effectiveness performances.

Methods

Randomised, controlled, multicentre, non inferiority, intervention trial, without blind for approach, in 9 district hospitals of the Province du Centre in Cameroon. 430 adult patients will be randomised in two groups ("simplified" approach or gold standard approach) with a 1:1 ratio and followed for 24 months.

In the "simplified" approach, the results of the HIV-1 viral load and CD4 cell count will not be available for the management of patients, the biologic assessment of tolerability will be limited and some clinical consultations will be performed by nurses under the physicians' responsibility; the remainder will be similar to the gold standard approach.

Planning

The study will start in the first semester of 2006. The full length of the study would be 36 months maximum (12 months for enrolment and 24 months for follow-up).

Expected results

Advices for increasing access to ART in Africa.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Men or women aged at least 18 years

Living in the health district of the hospital attended

Confirmed HIV-1 group M infection

Meeting one of the following criteria:

Stage III or IV (WHO classification)

Stage II (WHO classification) and total lymphocytes count ≤ 1200/mm3

Patient agreeing on monthly follow-up and treatment for 24 months

Signed informed consent

Exclusion Criteria:

HIV-1 group O or N, or HIV-2 infection

HIV-1 primary infection

Progressive tuberculosis in treatment and total lymphocytes count > 1200/mm3

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00301561

Locations

Cameroon

Hôpital de district d'Ayos

Ayos, Cameroon

Hôpital de district de Bafia

Bafia, Cameroon

Hôpital de district de Mfou

Mfou, Cameroon

Hôpital de district de Monatélé

Monatélé, Cameroon

Hôpital de district de Nanga Eboko

Naga Eboko, Cameroon

Hôpital de district de Ndikiniméki

Ndikiniméki, Cameroon

Hôpital de district d'Obala

Obala, Cameroon

Hôpital de district de Sa'a

Sa'a, Cameroon

Hôpital de district de Mbalmayo

Yaounde, Cameroon

Sponsors and Collaborators

French National Agency for Research on AIDS and Viral Hepatitis

Investigators

Study Chair:

Christian Laurent

Institut de Recherche pour le Developpement

Study Chair:

Eric Delaporte

Institut de Recherche pour le Developpement

Study Chair:

Sinata Koulla-Shiro

Hôpital Central, Yaoundé, Cameroun

Study Chair:

Charles Kouandack

Hôpital Central, Yaoundé, Cameroun

More Information

No publications provided by French National Agency for Research on AIDS and Viral Hepatitis